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Axsome偏头痛疗法再次接受FDA审查
2024-09-04 19:26
- Axsome Therapeutics (NASDAQ:AXSM) announced Wednesday that the U.S. Food and Drug Administration (FDA) accepted its resubmitted marketing application for its experimental migraine therapy AXS-07.
- The company submitted a new drug application, or NDA, for AXS-07 in 2021, targeting its FDA approval for the acute treatment of migraine in adults.
- The regulator accepted the NDA but issued a complete response letter, or CRL, in April 2022, rejecting the therapy.
- Axsome (AXSM) resubmitted the NDA, and the agency has accepted it as a Class 2 resubmission, setting January 31, 2025, as its target action date.
- Two Phase 3 trials, MOMENTUM and INTERCEPT, have already reached the co-primary endpoints for AXS-07 in the acute treatment of migraine. Another Phase 3 single-group trial for the candidate is currently underway.
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